Tailored Exercise Training Study Among Adults With HFpEF
Recruiting · NCT07223242 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Heart failure with preserved ejection fraction (HFpEF) is associated with a high morbidity and mortality burden. There are limited pharmacological options available for the treatment of HFpEF. Exercise intolerance (EI) is the cardinal symptom of HFpEF, which manifests as dyspnea and fatigue. EI leads to functional deconditioning and reduced quality of life (QOL), both of which elevate risk of death and hospitalization in patients with HFpEF. Supervised exercised training is associated with improvements in exercise capacity and QOL in adults with HFpEF. However, supervised exercise has not been widely utilized for the treatment of HFpEF due to logistical and fiscal barriers. This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with HFpEF, or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
Who can take part
Inclusion criteria
- Age\>= 18 yrs
- LVEF (Left Ventricular Ejection Fraction) \>= 50%
- History of HFpEF or at risk of HFpEF
- HFpEF diagnosis based on:- -HF hospitalization within 12 months-
- NT-proBNP \>360 pg/mL
- Risk of HFpEF based on:-
- \>2 risk factors (h/o diabetes, hypertension, obesity, physical inactivity by self-report)
- SPPB \< 10 or VO2\<60th percentile
- BMI \>=28 (for randomization in phase II)
- Able to use cell phone and mobile application
Exclusion criteria
- Hospitalization 1 month prior to baseline visit
- History of recurrent falls
- eGFR (Estimated Glomerular Filtration Rate) \<20ml/min/1.73m
- Active changes in HF therapies over 2 weeks prior to baseline visit
- Inability participate in exercise training therapy
- Inability to perform CPET (Cardiopulmonary Exercise Testing) testing
- Severe left side valvular heart disease
- End stage pulmonary disease, requiring continuous supplemental oxygen
- Major surgery within 3 months of screening or major elective surgery during the duration of the study.
- Unstable weight defined by \>5% change in body weight in last 30 days before first study visit.
- Pregnancy
Where it is running
1 location listed across 1 US state.
- University of Texas Southwestern Medical Center - Dallas, Texas, United States